Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery

Barbara Ann Karmanos Cancer Institute

Status: Completed

Conditions: Metastatic Cancer; Lung Cancer

Treatments: Procedure: cryosurgery; Procedure: positron emission tomography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00303901

CDR0000462091

P30CA022453 (U.S. NIH Grant/Contract)

WSU-0509002942

WSU-C-2975

Details and patient eligibility

About

RATIONALE: Cryotherapy kills tumor cells by freezing them. This may be an effective treatment for primary lung cancer or lung metastases that cannot be removed by surgery.

PURPOSE: This clinical trial is studying how well cryotherapy works in treating patients with primary lung cancer or lung metastases that cannot be removed by surgery.

Full description

OBJECTIVES:

• Estimate the local and distant failure rates after percutaneous thoracic cryotherapy (PTC) in patients with unresectable primary lung cancer or lung metastases.
• Estimate rates of PTC complications and adverse reactions.
• Determine the correlations between procedural parameters and follow-up imaging parameters, with the latter being used as surrogates of local and/or distant treatment failure.

OUTLINE: Patients undergo CT-guided percutaneous thoracic cryotherapy over 2 hours under local or general anesthesia. Grouped cryoprobes are inserted into the tumor, utilizing a freeze-thaw-freeze cycle, creating cytotoxic temperatures (less than -20°C to -40°C) that encompass the entire anticipated tumor volume.

Patients undergo positron emission tomography at baseline and after cryotherapy to assess tumor standard uptake variable.

After completion of study treatment, patients are followed at 1, 3, 6 and 12 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Enrollment: 40 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed malignant pulmonary neoplasm

• New lung lesion(s) with definitive clinical and imaging features of primary or metastatic disease allowed

  • Imaging findings compatible with localized treatment failure after prior cryotherapy allowed

• Malignant pleural effusion allowed provided it is associated with a distinct measurable pulmonary mass amenable to cryotherapy

• Metastatic disease must meet all of the following criteria:

  • Primary tumors have been resected or have been deemed controlled by other therapies
  • No other widespread metastases evident (e.g., multiple hepatic or brain metastases)

• Each pulmonary mass must be amenable to CT-guided percutaneous cryotherapy approach

• No more than 5 targeted masses for study therapy

  • Target mass defined as pulmonary, hilar, mediastinal, and/or chest wall mass > 1 cm, but < 10 cm in average diameter

• Unresectable disease by surgical consultation OR patient refused surgical options

• Nonenhanced and enhanced CT scan required within the past 6 weeks done at 4-5 mm increments with available soft tissue and mediastinal windows to assess size and extent of all thoracic tumors

  • PET scan required within the past 6 months noting the correlation with the above CT locations, if not already obtained by a combined PET/CT scanner

PATIENT CHARACTERISTICS:

• Karnofsky performance status (PS) > 60-100% OR WHO/ECOG/Zubrod PS 0-2

• FEV_1 > 30% of predicted

• DLCO > 40% of predicted

• Platelet count ≥ 70,000/mm^3

• INR < 1.5

• No uncontrolled coagulopathy or bleeding diathesis

• Not pregnant or nursing

• Negative pregnancy test

• No serious medical illness, including any of the following:

  • Uncontrolled congestive heart failure
  • Uncontrolled angina
  • Myocardial infarction
  • Cerebrovascular event within 6 months prior to study entry

• No medical contraindication or potential problem that would preclude study compliance

PRIOR CONCURRENT THERAPY:

• At least 7 days since prior aspirin and aspirin-like medications
• At least 3 days since prior warfarin, clopidogrel bisulfate, or similar compounds
• No concurrent drugs causing bleeding tendencies (e.g., aspirin, warfarin, or clopidogrel bisulfate)
• No concurrent participation in other experimental studies

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

cryosurgery

Experimental group

Description:

cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.

Treatment:

Procedure: positron emission tomography

Procedure: cryosurgery